Cleaning Validation Guidelines (GUIDE-0028)

Contact Name: Drug GMP Inspection Unit
Tel: 613-957-1492
Fax: 613-957-6709
E-Mail: GMP_questions_BPF@hc-sc.gc.ca

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Cover Letter

Health Products and Food Branch Inspectorate
Graham Spry Building, 3^rd Floor
250 Lanark Avenue
Address Locator # 2003D
OTTAWA, Ontario
K1A 0K9


January 4, 2008

07-128997-672

TO: ALL INTERESTED PARTIES

I am pleased to inform you that Health Canada has finalized the guidance document entitled "Cleaning Validation Guidelines (GUIDE-0028)", which is now available on Health Canada's Compliance and Enforcement website at:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php

This document has been reviewed as part of the Inspectorate's quality management process and has been amended to further clarify issues brought to the attention of the Inspectorate. Please note that no changes to the requirements were made, therefore, consultation is not deemed necessary.

Inquiries about this guidance document can be submitted in writing by mail to the Manager, Drug GMP Inspection Unit, HPFB Inspectorate, Graham Spry Building, A.L. #2002B, 250 Lanark Avenue, Ottawa, Ontario, K1A 0K9, by fax at 613 957-6709, or by e-mail at GMP_questions_BPF@hc-sc.gc.ca .

Original signed by

Diana Dowthwaite
Director General

Our mandate:

To take an integrated approach to managing the health-related risks and benefits of health products and food by minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food, and promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.

Health Products and Food Branch Inspectorate
Guidance Document
Cleaning Validation Guidelines

GUIDE-0028

Supersedes:
May 1, 2000

Date issued:
January 1, 2008

Date of implementation
January 1, 2008

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